The FDA continues its reorganization and as part of the transformation, the Office of Medical Policy has been rearranged into a so-called super office that will oversee regulation of prescription drug promotion and advertising; provide advice on clinical trial design; and direct policy issues concerning human subject protection and good clinical practices. The new director is Rachel Sherman and the deputy is Kathleen Uhl.
Meanwhile, the Division of Drug Marketing, Advertising, and Communications - which is known affectionately as Dee-Dee Mac - is being "elevated" into the Office of Prescription Drug Promotion. The new OPDP - rolls off the tongue like R2D2 - will be run by a familiar face - Tom Abrams, along with two associate directors - Mark Askine and Marci Kiester. Catherine Gray is the acting director for the Division of Professional Promotion, and Robert Dean is acting director, division of DTC promotion.
And the new Office of Medical Policy Initiatives, or OMPI, consists of an Immediate Office, the Division of Medical Policy Programs (DMPP), and the Division of Medical Policy Development (DMPD). The overall charter is to "develop and coordinate medical policy regulations and guidances that address the policy and program areas covered by the Super Office." Among its missions, support the Sentinel Initiative.
For those who enjoy the FDA's alphabet soup, the Patient Labeling Team (PLT) will be moving from the Office of Surveillance and Epidemiology (OSE), Division of Risk Management (DRISK) to OMPI, Division of Medical Policy Programs. The PLT is supposed to promote the safe and effective use of prescription meds. The OMPI director is Denise Hinton and the deputy director is Richardae Araojo.